Beth P. Weinman

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Beth Weinman is a member of the firm’s life sciences regulatory & compliance practice group. She focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices, cosmetics and dietary supplements.

As a former lawyer with the U.S. Food and Drug Administration, Beth brings valuable perspective to clients who turn to her for representation in government investigations, assistance with internal compliance investigations, FDA enforcement actions, product recalls and other agency engagement strategies.

Clients frequently look to Beth for representation when facing government investigations or engaging with FDA on regulatory compliance matters, particularly in connection with alleged manufacturing practice violations or inappropriate marketing. She has extensive experience representing clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, internal compliance investigations, and other enforcement actions before state and federal regulators. In addition, she regularly counsels clients through product recalls and withdrawals, responses to 483s and warning letters, and matters regarding marketing practices, manufacturing practices, data integrity issues and good clinical practices. Beth also represents clients in administrative litigation and assists in assessing risk in transactional matters.

Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the U.S. Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes (e.g., mail fraud, wire fraud, health care fraud, and conspiracies to defraud) under Title 18. She also worked on numerous parallel and independent FCA investigations involving FDA-regulated drugs and devices, and has significant experience in opioid-related investigations.

Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where she represented several pharmaceutical companies in government investigations and securities class-action lawsuits, among other matters.

Experience

Investigations and Litigation

Represented multiple global medical device manufacturers in parallel FCA and FDCA investigations into allegations related to reporting failures, manufacturing practice concerns, and consumer deception, leading to DOJ declinations.
Led multiple internal compliance investigations into allegations related to device quality concerns and potential misrepresentations to regulators.
Represented an individual and university in connection with a criminal investigation related to research fraud and use of an unapproved device.
Represented an individual in a criminal prosecution alleging conspiracy to defraud FDA in connection with drug manufacturing issues.
Represented pharmaceutical client in federal legal challenge to an FDA clinical hold imposed on a Phase II clinical trial.
Represented an international pharmaceutical distributor in a criminal investigation into potential violations of the FDCA and state laws governing wholesale distribution of prescription drugs.
Represented individual in FCA investigation related to regulation of HCT/Ps.
Led an internal compliance investigation for a U.S. pharmaceutical client in connection with manufacturing and data integrity issues at foreign facility.
Led internal investigation into alleged cGMP and QSR violations in connection with manufacturing of combination product.
Prepared client for questioning by FDA in connection with device investigation that lacked an investigational device exemption.

Medical Devices

Represented multiple global device manufacturers in assessments of potential enforcement risk associated with device nonconformities. Also counseled clients through disclosures to FDA and recall strategies.
Counseled medical device manufacturer through recall negotiations with FDA that resulted in a labeling correction rather than a product removal.
Represented and counseled client through self-report of compliance issues impacting multiple product categories and implementation of remediation plan.
Counseled multiple clients through emergency use authorization process for decontamination systems for personal protective equipment and for diagnostic tests in connection with COVID-19 pandemic.
Advised client in connection with device importation.

Pharmaceuticals/Biologics

Regularly advise clients on responses to FDA Form 483 observations, sampling controls, and advertising and promotional issues.
Advised client in connection with potential regulatory challenge and litigation options in connection with agency denial of certain labeling claims.
Counseled pharmaceutical manufacturer regarding potential civil and criminal exposure associated with data integrity issues in preclinical research.
Counseled rare disease drug manufacturer in connection with offering compassionate use access to an investigational drug.
Counseled pharmaceutical client in connection with outreach to FDA on question about compliance with unclear regulation.
Counseled client regarding OTC monograph compliance in connection with hand sanitizer.

Controlled Substances

Advise clients on DEA inspection readiness and loss investigation and reporting.
Advise clients on use of controlled substances in research.

Food and Cosmetics

Advised cosmetics company regarding FDA labeling requirements in connection with defense in state and federal consumer class action.
Advise food and cosmetics companies in connection with potential recall scenarios.

Credentials

Publications

Co-author, “When FDA Comes Knocking and What to Do About It: FDA Regulatory and enforcement Risks Relevant to Academic Medical Centers, Health Systems, and Research Institutions,” American Health Law Association’s Journal of Health and Life Sciences Law (August 2024)
Author, “Enhanced Quality Maturity to Reduce Drug Shortages,” Recall Index 2024 Edition (June 2024)
Co-author, “Implications of Loper Bright & Relentless for HHS-Regulated Entities,” Bloomberg Law (May 28, 2024)
Quoted, “‘An Incredible Undertaking’: 5 Takeaways from Philips Consent Decree,” MedTech Dive and Yahoo Finance (April 17, 2024)
Co-author, “The Road Ahead for Florida’s Drug Importation Program,” Law360 (March 6, 2024)
Quoted, “Philips Consent Decree ‘Worst Case Scenario’ for Respiratory Business,” MedTech Dive (February 6, 2024)
Co-author, “Seeing Past the Smoke: Regulatory Considerations for Public Health Research on Commercially Available Cannabis,” American Health Law Association “Health Law Weekly” (January 26, 2024)
Co-author, “First Circuit Affirms Convictions of Former Acclarent Executives Related to Off-Label Promotion of Medical Device,” Westlaw Today (January 3, 2024)
Co-author, “FDA Finalizes Guidance on Medical Device Manufacturer Cybersecurity Responsibilities,” Westlaw Today (November 9, 2023)
Co-author, “Preparing for FDA’s Surprise Foreign Drug Inspection Regime,” Law360 (June 28, 2023)
Quoted, “DOJ Enforcement: Talking with US FDA is Not Enough to Get Credit for Self-Disclosure,” Pink Sheet (May 31, 2023)
Co-author, “2022 Enforcement Review for FDA-Regulated Products: Back to Basics,” Ropes & Gray Alert (February 2, 2023)
Co-author, “Potential Upheaval for FDA Regulation of Stem Cell Clinics,” Law360 (January 3, 2023)
Co-author, “How Recalls Really Work,” chapter in “How FDA Really Works: Insights from the Experts” (November 2022)
Quoted, “GMP Violations Won’t Trigger Breach Of DOJ Compliance Agreement, Government Attorneys Say,” Pink Sheet (December 22, 2022)
Quoted, “US DOJ’s Corporate Crime Push Raises Concerns Over Criminalizing FDCA Violations,” Pharma Intelligence (December 13, 2022)
Co-author, “Federal Funding of Medical Countermeasures: Opportunities, Risks, and Enforcement Trends,” Food and Drug Law Institute’s (FDLI) Update (December 5, 2022) (Reprinted with permission of FDLI)
Co-author, “FDA’s Proposed Medical Device Rule is Promising, But Hasty,” Law360 (March 23, 2022)
Co-author, “Expect Aggressive Life Sciences Enforcement In 2022,” Law360 (February 14, 2022)
Co-author, “2021 Enforcement Review: FDA-Regulated Medical Products,” Ropes & Gray Article (January 31, 2022)
Co-author, “What’s Next for COVID-Era Emergency Use Medical Devices,” Law360 (January 19, 2022)
Quoted, “Attorneys Predict Pandemic-Related Rise in False Claims Allegations,” Medtech Insight (December 14, 2021)
Co-author, “The American Medical Product Supply Chain: Will COVID-19 Drive Manufacturing Back Home?” Food and Drug Law Institute’s Food and Drug Law Journal (October 15, 2021) Published with permission of FDLI and the Food and Drug Law Journal
Co-author, “Potential Costs of Reshoring Pharmaceutical Manufacturing,” Bloomberg Law (April 7, 2021)
Co-author, “Review of 2020 FDA Enforcement Activities,” Policy & Medicine (February 15, 2021)
Co-author, “Deconstructing the Consent Decree: A Primer and Recent Trends for FDCA Injunctions,” Food & Drug Law Institute Update Magazine (Winter 2020)
Co-author, “Questions Raised By FDA's New Lab Test Policy,” Law360 (October 20, 2020)
Co-author, “FDA Announces It Will No Longer Review EUA Requests for COVID-19 Laboratory Developed Tests,” Ropes & Gray Alert (October 9, 2020)
Co-author, “District Court Upholds Acclarent Executives Strict Liability Conviction for Off-Label Promotion,” Ropes & Gray Alert (September 17, 2020)
Co-author, “Keeping Track of the Quacks: Drug and Device Enforcement in the COVID-19 Era,” Food and Drug Law Institute Update Magazine (September 2020)
Co-author, “HHS Lab Test Rule's Likely Impact During And After COVID-19,” Law360 (August 31, 2020)
Co-author, “Analysis: FDA Response to COVID-19: A Shifting Landscape,” Ropes & Gray Alert (June 29, 2020)
Co-author, “Pandemic May Spur Reform of Lab Test Regulation,” Law360 (April 7, 2020)
Co-author, “Will the Coronavirus Spur Passage of LDT Reform Legislation,” Ropes & Gray Alert (March 25, 2020)
Co-author, “2019 FDA Enforcement Review: Drugs, Biologics, Devices, and Dietary Supplements,” Ropes & Gray FDA Regulatory Alert (February 4, 2020)
Co-author, “When DOJ Seeks Dismissals Of Life Sciences FCA Cases,” Law360 (December 12, 2019)
Co-author, “Kisor May Be A New Dawn For Challenges To FDA Actions,” Law360 (December 2, 2019)
Co-author, “A Guide To FCA Cooperation Credit For Life Sciences Companies,” Law360 (June 18, 2019)
Co-author, “FDA Draft Guidance On Medical Device Inspections Is Limited,” Law360 (May 10, 2019)
Co-author, “2018 FDA Enforcement Review: Drugs, Biologics And Devices,” Law360 (January 28, 2019)
Profiled, “Fresh From US FDA’s Chief Counsel Office, Beth Weinman Talks Qui Tam and Compliance,” Medtech Insight (November 13, 2018)
Profiled, “Ropes & Gray Adds Ex-FDA Enforcement Pro In DC,” Law360 (October 26, 2018)

Presentations

Presenter, “Laboratory Developed Tests (LDT) and In Vitro Diagnostics as Regulated Medical Devices,” MassMEDIC Regulatory Roundup (November 13, 2024)
Speaker, IBA Annual Conference in Mexico City, “AI Opportunities and Challenges in the Medical Devices Sector Across the Globe” (September 16, 2024)
Moderator, “Compliance Risks for Rare Disease-Focused Life Sciences Companies,” Ropes & Gray Second Annual Rare Disease Forum (May 7, 2024)
Planning Committee Chair, Food and Drug Law Institute Enforcement, Litigation and Compliance Conference (December 6-7, 2023)
Presenter, “Top Cases in Enforcement and Compliance: Challenges to FDA and Other Federal Agency Authority,” Food and Drug Law Institute Enforcement, Litigation and Compliance Conference (December 6, 2023)
Moderator, “DOJ Agreements, Dual Reporting and the Role of the Compliance Officer,” 24^th Annual Pharmaceutical and Medical Device Ethics and Compliance Congress (October 26, 2023)
Co-moderator, 9^th Annual International Bar Association World Life Sciences Conference in Washington, D.C. (June 1, 2023)
Presenter, “The Shift Toward U.S. Pharmaceutical Manufacturing: Considerations in Attaining the Right Global Mix,” Fierce Pharma webinar (March 30, 2023)
Presenter, “DOJ, FDA, and Compliance in Criminal Violations of the FDCA (Oh My!),” Food and Drug Law Institute’s Enforcement, Litigation and Compliance Conference Washington, D.C. (December 8, 2022)
Presenter, “New and Emerging Risks for Medical Devices” at the 23^rd Pharmaceutical and Medical Device Ethics and Compliance Congress (October 24, 2022)
Moderator, False Claims Act panel at Food & Drug Law Institute's 2021 Enforcement, Litigation and Compliance Conference (December 10, 2021)
Speaker, “Everything But the FDCA: An Evolving Enforcement Arsenal,” FDLI Annual Conference (May 19, 2021)
Speaker, “Outlook 2021: Washington, D.C. Updates and Insights on Life Sciences and Health Care,” Ropes & Gray Teleconference (February 25, 2021)
Speaker, “Enforcement and Litigation,” FDLI Fundamentals of Vaccine Regulation – Scientific Ingenuity and Rigorous Review (February 4, 2021)
Speaker, “Evolving Off-Label Enforcement Theories,” FDLI Enforcement, Litigation, and Compliance Conference (December 15-16, 2020)
Speaker, “The American Pharmaceutical Supply Chain: Will COVID-19 Drive Manufacturing Back Home?” FDLI 2020 Symposium (November 12-13, 2020)
Moderator, “Continued Reliance on Foreign Drug Manufacturing and the Drug Supply Chain: Manageable Risk or Public Health Concern,” FDLI On-Demand Webinar (September 16, 2020)
Speaker, “What Patient Organizations Should Know to Interact with FDA During COVID-19,” FDLI Conference (September 2, 2020)
Speaker, “COVID-19: Introduction to FDA’s Legal Authorities and Emerging Issues,” FDLI Conference (August 18-19, 2020)
Speaker, “Food and Drug Regulatory Trends and Developments: Navigating Implications for the Year Ahead,” The Knowledge Group Webinar (August 5, 2020)
Moderator, “Enforcement Trends,” FDLI Regenerative Medicine Conference (April 2, 2020)
Speaker, “Violations, Enforcement and International Issues,” FDLI Introduction to Biologics and Biosimilars Law and Regulation (April 1, 2020)
Speaker, “Outlook 2020,” Ropes & Gray Teleconference (January 30, 2020)
Speaker, “Navigating the Intersection Between Litigation Tactics and Regulatory Issues,” FDLI Enforcement, Litigation, and Compliance Conference (December 11-12, 2019)
Speaker, “With Great Influence Comes Great Responsibility,” FDLI 2019 Symposium (November 15, 2019)
Speaker, “Mini Summit XXIII: Social Media Engagement by Manufacturers,” 21^st Annual Pharmaceutical and Medical Device Compliance Congress (November 4-6, 2019)
Presenter, “Violations, Enforcement and International Issues” Food and Drug Law Institute’s Introduction to Biologics and Biosimilars Law and Regulation, Washington, D.C. (October 2, 2019)
Moderator, “Focus on Investigations: Government Trends and Best Practices for Internal Investigations,” FDLI Annual Conference (May 2-3, 2019)
Speaker, “Outlook 2019,” Ropes & Gray Teleconference (January 23, 2019)

Experience

Credentials

Education

Admissions

Publications

Presentations

Areas of Practice